Kornimate/medical-research-clean huggingface dataset:
a pilot study: a non-opioid technique for postoperative adenoidectomy pain relief in pediatric patients

Conditions: Adenoid Hypertrophy

Summary: this proposed study will assess analgesic efficacy of a multi-modal, non-opioid analgesic regimen for providing surgical analgesia in pediatric patients undergoing adenoidectomy and to assess recovery characteristics in the post-anesthesia care unit (pacu) and at home following surgery.


Eligibility criteria:
inclusion criteria: 1. patients undergoing adenoidectomy ± bilateral ear tube placement 2. have a parent/guardian who are compliant with routine medical care, capable of subjective evaluation and able to read, understand and sign the informed consent in accordance with irb regulations exclusion criteria: 1. an american society of anesthesiologists physical status ≥ 4 (severe disease that is life threatening); 2. a known hypersensitivity or allergy to any of the study medications; 3. a history of chronic opioid use prior to surgery; 4. coexisting renal or hepatic disease; 5. morbid obesity (bmi% ≥ 99).
prospective randomized study comparing laparoscopic versus open partial nephrectomy

Conditions: Kidney Neoplasms

Summary: partial nephrectomy is considered the standard treatment for renal tumors smaller than 7 cm. with the evolution of image diagnostic tools and dissemination of its use, smaller tumors are being commonly diagnosed and treated. the partial open nephrectomy is still considered the gold standard technique for nephron sparing surgery, especially when the surgeon is not experienced with the minimally invasive surgery. in the last 15 years, uncountable minimally invasive techniques were developed, including the laparoscopic partial nephrectomy. the objective of this study is compare the partial laparoscopic nephrectomy to open partial nephrectomy in terms of perioperative, oncologic and functional outcomes. a balanced randomized prospective trial will be conducted. one group of patients will be submitted to to open partial nephrectomy while the other group of patients will be submitted to laparoscopic partial nephrectomy. a randomized prospective trial comparing the two techniques is necessary to determine the differences in outcomes between them and if the laparoscopic partial nephrectomy can be performed without harms to the patients.


Eligibility criteria:
inclusion criteria: * patients with renal tumor ct1n0m0; (\<7 cm) * normal renal function (serum creatinine \ 60ml/min/1.73m2) * tumor only exclusion criteria: * functional or anatomical solitary kidney * horseshoe kidney, ectopic or malformed * clinical contraindication to surgery * contraindication to laparoscopic surgery * association with other renal pathologies * evidence of lymph node or systemic disease in preoperative staging

Keywords: kidney neoplasms, minimally invasive surgery, renal cell carcinoma
real-life use of the crohn's disease exclusion diet (cded) in adult patients with crohn's disease

Conditions: Crohn Disease

Summary: this study explores the effectiveness od the crohn's disease exclusion diet (cded) as a tretament for adults with mild-to-moderate crohn's disease (cd). the hypotesis is that cded, by excluding specific dietary components thought to exacerbate gut inflammation, can induce remission in cd patients more effectively than a control diet based on the mediterranean pattern. conducted as an open-label randomized trial, the research aim to provide real-world evidence of cded's safety and its inpact on clinical remission, body composition and overall quality of life for cd patients.


Eligibility criteria:
inclusion criteria: * mild-to-moderate crohn's disease activity (hbi between 5 and 16) exclusion criteria: * concomitant treatment with corticosteroids, antibiotic therapies and nutraceutical supplements, treatment with biological drugs and traditional immunosuppressants started less than 24 weeks before enrollment, presence of active fistulas or abscesses, gastrointestinal tract surgery less than 6 months to randomization, coeliac disease, type 1 diabetes mellitus, uncontrolled type 2 diabetes mellitus, acute coronary disease (unstable angina, myocardial infarction), advanced acute or chronic liver disease, congestive heart failure (nyha class iii-iv), acute and chronic nephropathies (grf\<30 ml/min according to the ckd-epi formula), presence of acute infectious diseases and pregnancy.
molecular signatures of cutaneous dupilumab response

Conditions: Atopic Dermatitis

Summary: this study examines the effect of il4ra blockade with dupilumab on the immune cells of atopic dermatitis skin lesions.

this is a one-arm, open-label study to examine the effect of dupilumab. dupilumab is a fda-approved medication for the treatment of atopic dermatitis. this study will examine how dupilumab affects immune cells within atopic dermatitis skin lesions. fifteen subjects with moderate to severe atopic dermatitis will be enrolled. biopsy samples will be collected and undergo molecular profiling to correlate profiles with and to predict dupilumab treatment response.

Eligibility criteria:
inclusion criteria: 1. 18 years of age or older 2. atopic dermatitis with a easi (eczema area and severity index (easi)) score of ≥7 exclusion criteria: 1. known pregnancy 2. known immunodeficiencies 3. known parasitic infection -
phase 1 study to evaluate medi4736 in subjects with myelodysplastic syndrome

Conditions: Myelodysplastic Syndrome

Summary: this is a multicenter, open-label, phase 1 study to assess the safety and antitumor activity of medi4736 as monotherapy or in combination with tremelimumab with or without azacitidine in subjects with myelodysplastic syndrome after treatment with hypomethylating agents

a dose-escalation and dose-expansion study of medi4736 (a monoclonal antibody that targets programmed cell death-1 ligand 1 \[pd-l1\]) to evaluate the safety, tolerability, pk, im, and antitumor activity of medi4736 as monotherapy or in combination with tremelimumab with or without azacitidine in adult patients with myelodysplastic syndrome.

Eligibility criteria:
inclusion criteria: adult male or female subjects with pathologically confirmed mds who failed to respond, relapsed after an initial response, or were unable to tolerate hypomethylating agents, ecog performance status of 0 - 2, and adequate organ and marrow function. exclusion criteria: concurrent chemotherapy, immunotherapy, biologic, or hormonal therapy for cancer treatment, prior mab against ctla-4, pd-1, or pd-l1, alllogenic or haploidentical transplant, current immunosuppressive medication or autoimmune or inflammatory disease.

Keywords: myelodysplastic syndrome mds
immune response to hepatitis c virus

Conditions: Hepatitis C; HIV Infections

Summary: the purpose of the study is to investigate the immune response to hepatitis c virus to determine why some people clear the virus and others develop chronic infection. changes in immune response once hepatitis c therapy is begun will also be examined. if patients are also hiv+, the effect of antiretroviral therapy on the recovery of hepatitis c immunity will be investigated.

we will analyze the peripheral (blood) and intrahepatic (liver) immune response in hepatitis c infection in patients with clear hepatitis c infection and those who develop chronic infection. we hope to determine immune responses that are important for eliminating the infection. currently, the treatments for hepatitis c are not effective for everyone. for those patients enrolled who begin hepatitis c treatment, we will evaluate the immune system of people who respond compared to those who do not respond. if the patient is hiv positive, the change in hepatitis c immune response once various hiv medicines (antiretrovirals) are started will also be examined. any treatment for hepatitis c or hiv will be determined by the patient's primary physician and will not be affected by enrollment in the study. blood samples of \~70 cc will be obtained no more than once per week. patients who begin hepatitis c therapy or antiretroviral therapy if hiv coinfected will provide serial specimens for examination. patients who undergo liver biopsy as a part of their routine hepatitis care will provide a sample for further studies of the immune response to see if it is different in the liver compared to the blood.

Eligibility criteria:
this is not a clinical trial. inclusion criteria * hcv infected and uninfected (controls) * women * minorities exclusion criteria * children * individuals who cannot or will not provide informed consent

Keywords: hepatitis c hiv immunopathogenesis hiv-1
tki therapy based on molecular monitoring in allogeneic-hsct recipients with philadelphia chromosome-positive acute lymphoblastic leukemia

Conditions: Philadelphia Chromosome Positive Acute Lymphocytic Leukemia; Stem Cell Transplantation; Minimal Residual Disease

Summary: the purpose of this study is to evaluate the efficacy of tyrosine kinase inhibitor(tki) therapy based on molecular monitoring of bcr/abl levels in philadelphia chromosome-positive acute lymphoblastic leukemia (ph+ all)undergoing allogeneic hematopoietic stem cell transplantation(allo-hsct).

philadelphia chromosome (ph) is a reciprocal chromosomal translocation t(9;22）(q34;q11), which leads to the formation of the bcr/abl oncogene. ph is the most frequent cytogenetic abnormality in all characterized by poor outcome. with the bcr/abl protein tki, imatinib, in the combination chemotherapy regimes for newly diagnosed ph+ all, more than 95% of patients can achieve complete remission(cr). several studies have shown decreased relapse rates and improved disease-free survival for patients with imatinib-based treatment prior to allo-hsct. however, the efficacy of maintenance therapy with imatinib after transplant for ph+ all patients is still uncertain. in addition, acquired resistance to imatinib is frequently caused by point mutations in bcr/abl that inactivate imatinib. detection of minimal residual disease (mrd) after transplant is associated with an increased risk of relapse. reverse transcription-polymerase chain reaction (rt-pcr) is a sensitive method for detecting low-level bcr/abl transcripts to assess mrd in ph+ all. it has been corroborated by several reports that detection of mrd after sct was predictive of imminent relapse. in this study, we will evaluate the safety and efficacy of tki therapy, when initiating treatment based on bcr-abl transcript levels after allo-hsct.

Eligibility criteria:
inclusion criteria: * a patient age of 14-65 years * allo-hsct recipient with ph+ all * subjects (or their legally acceptable representatives) must have signed an informed consent document indicating that they understand the purpose of and procedures required for the study and are willing to participate in the study. exclusion criteria: * any abnormality in a vital sign (e.g., heart rate, respiratory rate, or blood pressure) * patients with hematological relapse, extramedullary involvement of leukemia * patients with any conditions not suitable for the trial (investigators' decision)

Keywords: philadelphia chromosome acute lymphoblastic leukemia allogeneic hematopoietic cell transplantation minimal residual disease tyrosine kinase inhibitor
comparison of absorbable sutures in perineal laceration repair

Conditions: Perineal Laceration Repair

Summary: the purpose of this study is to determine the difference in pain scales between absorbable suture types for second-degree perineal laceration repair.


Eligibility criteria:
inclusion criteria: * at least 18 years of age * able to sign informed consent * vaginal laceration that requires sutures but does not involve the anal sphincter (third-degree tear) or rectal mucosa (fourth-degree tear) exclusion criteria: * inability to speak and understand english or spanish * previous diagnosis of vulvodynia, dyspareunia, or other chronic vulvar pain syndrome * extensive perineal warts or vulvar varicosities

Keywords: perineal trauma perineal laceration persistent perineal pain
a randomized controlled study on the efficacy and safety of neoadjuvant radiotherapy combined with systemic therapy for early-stage breast cancer

Conditions: Breast Cancer

Summary: a total of 340 early-stage breast cancer patients with axillary lymph node biopsy-confirmed positivity were enrolled and divided into two groups. the control group received neoadjuvant systemic therapy followed by surgery and adjuvant radiotherapy. the experimental group received neoadjuvant systemic therapy and neoadjuvant radiotherapy followed by surgery. the treatment response of breast cancer, patient survival time, and treatment safety were subsequently evaluated.

this study is a randomized, controlled, open-label clinical trial, planned to enroll 340 early-stage breast cancer patients with axillary lymph node biopsy-confirmed positivity. participants will be divided into two groups. the control group will receive neoadjuvant systemic therapy, followed by surgery and adjuvant radiotherapy. the experimental group will receive neoadjuvant systemic therapy combined with neoadjuvant radiotherapy before undergoing surgery. after providing full informed consent and signing the informed consent form, eligible participants will enter the trial period upon screening. within 72 hours of enrollment confirmation, participants will begin neoadjuvant therapy. patients in the control group will receive a neoadjuvant systemic therapy regimen selected by their physician, followed by surgery and adjuvant radiotherapy. patients in the experimental group will receive both neoadjuvant systemic therapy and neoadjuvant radiotherapy. the radiotherapy regions will include the whole breast, supraclavicular and infraclavicular areas, and internal mammary regions, with a dose of 50 gy over 25 fractions, plus a tumor bed boost of 10-16 gy over 4-8 fractions. primary endpoint: residual cancer burden (rcb) 0/i. secondary endpoints: event-free survival (efs) invasive disease-free survival (idfs) overall survival (os) quality of life scores ecog performance status scores surgical incision healing scores adverse events (aes) inclusion criteria: participants must meet all of the following criteria to be eligible for the trial: 1. female patients aged ≥18 years and ≤65 years with newly diagnosed breast cancer; 2. early-stage or locally advanced invasive breast cancer confirmed by histopathology according to the latest asco/cap guidelines, meeting the following conditions:axillary lymph node biopsy-positive;ecog performance status score of 0-1; 3. presence of at least one measurable lesion based on recist 1.1 criteria.

Eligibility criteria:
inclusion criteria: * female patients aged ≥18 years and ≤65 years； * newly diagnosed breast cancer; * axillary lymph node biopsy-positive; * ecog performance status score of 0-1; exclusion criteria: * metastatic breast cancer or bilateral breast cancer; * inflammatory breast cancer; * pregnancy and lactation;

Keywords: radiotherapy system therapy
effects of menthol on dyspnoea in copd patients

Conditions: Copd; Dyspnea; Lung Diseases

Summary: chronic obstructive pulmonary disease (copd) is characterised by non-reversible bronchial obstruction associated with systemic disorders and comorbid factors. dyspnoea is a common symptom among patients with chronic obstructive pulmonary disease (copd). dyspnea is the primary symptom limiting exercise and daily activities in these patients. it has been reported that breathing cold air could decrease dyspnoea induced by exercise and could improve exercise performance. the aim of this study is to carry out the effect of cooling sensation induced by menthol chewing-gum on dyspnoea and exercise performance among patients with copd.


Eligibility criteria:
inclusion criteria: * a diagnosis of copd * dyspnea in daily living (2-4 on the modified medical research council dyspnea scale) * clinically stable exclusion criteria: * exercise contraindication any musculoskeletal problems, cardiovascular or neurological comorbidities that limits exercise. * exacerbation during the study * inability to chew or patients with swallowing disorders

Keywords: copd menthol exercise dyspnea
effectiveness of a brief cognitive and behavioral skills program on stage transitions for chronic ketamine abusers

Conditions: Substance Use Disorders

Summary: in recent years ketamine abuse becomes prevalent in youth in some asian countries. chronic ketamine abuse may lead to uropathology and cognitive impairments. no pharmacological interventions have been identified as effective for treating ketamine abuse or helpful in achieving or maintaining abstinence from ketamine. cognitive-behavioral treatment is currently an important psychosocial intervention for addictive problems. this study aimed to test whether a brief cognitive-behavioral training program has a positive influence on stage transitions among ketamine abusers.

409 ketamine abusers were recruited in this study, with 285 ketamine abusers participated in a 6-hour brief cognitive-behavioral intervention and 124 ketamine abusers attended educational lectures on ketamine abuse. a brief cognitive-behavioral intervention was applied to teach ketamine abusers about stimulus control, refusal skills, communication skills, decisional balance, and infectious diseases prevention. stage of change and knowledge about ketamine were assessed before and after the intervention.

Eligibility criteria:
inclusion criteria: * ketamine use in 30 days * more than 18 years old exclusion criteria: * no brain damage

Keywords: substance abuse cognitive behavioral treatment ketamine stage of change
cognitive control training as an adjunct to behavioral activation therapy in the treatment of depression

Conditions: Depression

Summary: the purpose of this study is to evaluate the potential effects of a cognitive training program when combined with a particular form of psychotherapy (behavioral activation therapy) for depression. behavioral activation therapy targets changes in behavior as a method for improving a depressed individual's thoughts, feelings, and overall quality of life. this study is designed to test whether a computerized brain exercise called cognitive control training can enhance the effects of a 5-session behavioral activation therapy program. cct has been shown to reduce depressive symptoms in two other studies, but it has not yet been combined with behavioral activation therapy. the investigators hypothesize that individuals assigned to the behavioral activation plus cognitive control training condition will demonstrate reduced depressive symptoms from pre to post treatment compared with those assigned to the behavioral activation plus computerized control condition. the investigators hypothesize that these gains will be maintained at one-month follow up.


Eligibility criteria:
inclusion criteria: 1. adults ages 18-65 2. primary psychiatric diagnosis of major depressive disorder 3. ability to read and speak english sufficiently to complete study procedures 4. if taking antidepressant or anxiolytic medication, participants must be taking a stabilized dose for a minimum period of at least 8 weeks prior to entry into the study 5. willingness and ability to comply with the requirements of the study protocol exclusion criteria: 1. lifetime history of bipolar disorder or psychotic disorder 2. neurological disorder such as parkinson's disease or traumatic brain injury 3. alcohol or substance dependence within the past 6 months 4. substantial suicide risk 5. concurrent psychotherapy initiated within 2 months of baseline, or ongoing psychotherapy of any duration directed specifically toward treatment of the depression other than general supportive therapy 6. current use of antipsychotics, stimulants, or modafinil

Keywords: depression major depressive disorder behavioral activation cognitive training
observation and progressive strength training after hip fracture

Conditions: Exercise

Summary: this is a randomized, controlled; single-blind parallel group trial carried out with hip fracture patients, starting at 12 weeks post fracture. patients were approached during their acute stay in hospital, followed without any extra intervention for 12 weeks, and then randomized in a 2:1 manner to either intervention or control for the next 12 weeks. after the first 12 weeks intervention the intervention group were divided into two groups and randomized to an new single-blind parallel group trial for further intervention.


Eligibility criteria:
inclusion criteria:at 12 weeks postoperative: 1. age at least 65 years 2. not living in nursing home 3. were able to undergo physical therapy for the hip fracture 4. scoring of 23 or more (out of 30) on the mini mental state examination exclusion criteria: 1. permanently institutionalized 2. had metastatic cancer 3. suffered from multi-trauma.

Keywords: strength function mobility
effectiveness of chiropractic application for acute low back pain

Conditions: Low Back Pain, Mechanical

Summary: the aim of this project is to investigate the effectiveness of chiropractic application on patients who have undergone routine medication as a standard hospital treatment for mechanical low-back pain as described in the clinical practice guidelines


Eligibility criteria:
inclusion criteria: * aged between 19 and 65. * acute lower-back pain, persisting less than 6 weeks, meeting the diagnostic classification of 1 or 2 according to the quebec task force on spinal disorders exclusion criteria: * previous spine surgery * spinal nerve root irritation or deficits, * pregnant women, * lower-back pain due to occupational accidents * obesity status (body mass index\> 30). * chronic lower-back pain longer than 6 weeks.

Keywords: mechanical low back pain chiropractics analgesic-anti-inflammatory myorelaxant thiocolchicoside
effectiveness of the selective serotonin reuptake inhibitor,citalopram (cipralex), in prurigo nodularis

Conditions: Prurigo Nodularis

Summary: prurigo nodularis (pn) is a common dermatological disorder, manifested as scaly nodules which appear mainly on the extensor surfaces of the limbs. pn may appear secondarily to skin scratching in chronic hepatitis, liver cirrhosis, uremia, hypothyroidism etc. nevertheless, in many cases no underlying physical disease is present. according to the literature, in fifty percent of the patients there is co-morbidity with depression, anxiety or somatoform disorders. we hypothesize that a group of these patients may benefit from antidepressant therapy.


Eligibility criteria:
inclusion criteria: * prurigo nodularis * age: 18-70 years * agreed to participate exclusion criteria: * younger than 18 or older than 70 * pregnant or lactating women * chronic diseases: cancer, neurological disorders, diseases that are known to be associated with pruritus such as liver cirrhosis, uremia, etc. * sensitivity to cipralotam * psychosis, bi-polar disorder, substance addiction, use of antidepressant in the previous year * use of systemic therapies to prurigo nodularis such as thalidomide, cyclosporine